February 2013 FDA Recall Drug by Teva Pharmaceuticals Usa, Inc.
D-237-2013 - Failed Content Uniformity Specifications

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on February 7, 2013 for the product Drug. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed in NC and the recall is currently terminated.

Recall Number: D-237-2013

Reason for Recall
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
Initiated
02-07-2013
Reported
04-10-2013
Quantity
3 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64305
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2014
Product Description About Product Description
Full technical description of the product.
CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96

Batch or Lot Expiration Information

Lot# 32900136A, Exp. 05/14